Human Subjects Research

---

Human Subjects

All research that involves the use of humans (e.g., survey, experimental, evaluation, biomedical research) must be approved by the Institutional Review Board (IRB), according to the University's Assurance of Compliance Agreement with the Department of Health and Human Services.

The Institutional Review Board is charged with the responsibility of maintaining institutional compliance with the U.S. Office of Human Research Protections (OHRP) regulations regarding the use of human subjects in research.

A human subject is defined by the Code of Federal Regulations (CFR) as "a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable state and local law and is not directly regulated by the federal human subject regulations.

Research is defined in the Code of Federal Regulations (CFR) as "a systematic investigation designed to develop and contribute to generalizable knowledge."

Examples of activities that constitute research include:

• any study intended to result in publication or public presentation;

• any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish; or

• any use of an investigational drug or device.

Thus, research with human subjects includes survey and interview research, as well as evaluation studies.

An example of an activity that is not research would be any evaluation of an employee, course, program, or service in which such evaluation is not designed to lead to generalizable knowledge. If an activity does not involve research, it does not require approval or review by the IRB. If the investigator has any doubt as to whether an activity constitutes research, he or she should contact the Compliance Coordinator, Robin Pyles , at (270) 745-3360.

For all research activity, the investigator- whether an administrator, faculty member, staff member, or student- must file a protocol, or description of the procedure(s) to be used to gather information from subjects, with the IRB. The IRB must then approve the protocol prior to the collection of any data or research information from the research participants.

The guidelines have provisions for exemption of some studies that involve no risk to subjects and for expedited review for some types of studies involving no more than minimal risk to subjects. The determination of the type of review required must (by federal mandate) be made by the Institutional Review Board.